A supplement in a trial — it does not become a medicinal product by virtue of that fact
The first question any experienced regulatory adviser asks is: does conducting this trial change the regulatory status of the product?
This question has significant practical consequences. If a trial is designed and conducted in a manner appropriate to a clinical trial of a medicinal product — controlled randomisation, blinding, a therapeutic objective expressed in a primary endpoint — regulatory authorities may determine that the product de facto meets the definition of a medicinal product under Article 2(32) of the Pharmaceutical Law Act, i.e. that it is "intended for the prevention or treatment of disease". In such a situation, the trial would require authorisation from the Office for Registration of Medicinal Products (URPL) and registration in CTIS — a regulatory system with an entirely different logic, cost structure and timeline.
A properly designed food supplement trial does not measure therapeutic efficacy; rather, it documents the effect on nutritional status, a selected physiological parameter or a bodily function. This distinction is subtle but critical when formulating objectives, selecting endpoints and constructing the protocol.
Expert Tip: A well-designed food supplement trial does not "treat" participants. It observes or supports — and that is precisely what every trial document should reflect.
Legal basis: research experiment under Article 21(3) of the Act on the Professions of Physician and Dentist
Clinical trials of food supplements conducted with human participants are carried out in Poland under the provisions governing medical experiments. The applicable legal basis is Article 21(3) of the Act of 5 December 1996 on the Professions of Physician and Dentist, which concerns research experiments — i.e. those whose sole purpose is to expand medical knowledge and which may be conducted on both sick and healthy individuals.
This provision gives rise to three absolute requirements:
First: opinion of the Bioethics Committee. Without a favourable resolution from the competent Bioethics Committee, the experiment may not commence. The Committee evaluates the protocol, the participant-facing documentation and the qualifications of the research team. The application may only be submitted by a licensed physician — the Principal Investigator — who is responsible for ensuring that the conduct of the experiment complies with the approved protocol.
Second: informed and voluntary consent of the participant. Before being enrolled in the trial, each participant must receive full information about its objectives, risks, expected benefits and the right to withdraw without consequence. The consent form is a legal document, and its signature must precede any intervention. Failure to obtain properly informed consent renders participation invalid and may give rise to criminal liability.
Third: medical supervision. The experiment must be conducted under the direct supervision of a physician. If the trial takes place at multiple sites, each site requires a designated local investigator acting under the supervision of the Principal Investigator.
flowchart TD
A[1. Bioethics Committee Opinion] --> B[2. Informed Consent of Participant]
B --> C[3. Medical Supervision — Physician]
C --> D[Experiment may commence]
A -. absent .-> STOP[STOP: experiment unlawful]
B -. absent .-> STOP
C -. absent .-> STOP
style D fill:#22c55e,color:#fff
style STOP fill:#ef4444,color:#fff
style A fill:#1e40af,color:#fff
style B fill:#1e40af,color:#fff
style C fill:#1e40af,color:#fff
Participants — not patients, but with full rights
Individuals taking part in a food supplement trial are participants in an experiment, not patients in the clinical sense. This is an important distinction — they do not have a therapeutic relationship with the investigator, and the trial is not a treatment. Nevertheless, their rights are full and unconditionally enforceable.
A participant has the right to withdraw from the trial at any time, without giving any reason and without any consequences whatsoever. The trial documentation should confirm this expressis verbis — and this must not be a mere formal declaration undermined in practice by provisions that restrict its exercise.
Participants' personal data are subject to the GDPR, with all the resulting obligations on the data controller — pseudonymisation, purpose limitation, right of access, right to erasure, and the duty to provide information. The protocol and contracts should precisely specify who is the data controller, on what legal basis the data are processed and for how long.
A participant who is unable to give informed consent — for example due to their state of health — may only take part in the trial if their legal representative consents on their behalf, subject to additional requirements being met.
Contracts — who with whom, and on what terms
Conducting a clinical trial of a food supplement requires several contracts, the scope and parties to which should be carefully considered before the project begins.
The contract between the sponsor and the research site governs the provision of clinical infrastructure, the rights and obligations of the site as the location where the trial is conducted, remuneration, and the rules of liability for harm caused to participants. In a multi-centre trial, each site has a separate contract — and each must be consistent with the protocol, even though the individual arms of the trial may differ in the scope of procedures.
The contract with the Principal Investigator is typically a contract for services, the subject matter of which is the coordination of the entire experiment, submission of the application to the Bioethics Committee, supervision of local investigators and preparation of reports. The Principal Investigator is not a party to the contract with the site — that is a separate legal relationship.
The contract with the scientific or academic coordinator (if this role is performed by someone other than the Principal Investigator) governs protocol development, scientific oversight, data analysis and preparation of the final report.
What is essential in each of these contracts is a precise delineation of responsibilities. Who notifies the Bioethics Committee of protocol amendments? Who informs participants of new safety data? Who is the data controller? Who issues invoices for individual procedures? Leaving these questions unanswered leads to disputes during implementation.
graph TD
S[Sponsor] --> U1[Contract with research site]
S --> U2[Contract with Principal Investigator]
S --> U3[Contract with coordinator]
GB[Principal Investigator] --> WN[Application to Bioethics Committee]
KB[Bioethics Committee] --> UCH[Resolution]
GB --> NAD[Supervision of local investigators]
style S fill:#1e40af,color:#fff
style GB fill:#0f766e,color:#fff
style KB fill:#7c3aed,color:#fff
style UCH fill:#22c55e,color:#fff
style U1 fill:#334155,color:#e2e8f0
style U2 fill:#334155,color:#e2e8f0
style U3 fill:#334155,color:#e2e8f0
style WN fill:#334155,color:#e2e8f0
style NAD fill:#334155,color:#e2e8f0
The investigational product — its legal status in context
A food supplement used in a trial is the investigational product within the meaning of the protocol and contracts, but it is not a medicinal product and is not subject to the regulations governing clinical trials of medicinal products. This does not mean, however, that it may be treated casually.
The protocol should specify its composition, form, dosage and storage conditions. The sponsor is responsible for supplying the product to the sites conducting the intervention arm. Every product dispensed to a participant should be recorded. If the trial is observational in nature with respect to another substance (for example, observing participants who are using a particular preparation of their own volition), the sponsor is not a party to that decision and does not supply that preparation — a fact that should be stated expressis verbis in the documentation in order to exclude the risk of the trial being classified as interventional.
Liability insurance
The sponsor of a medical experiment conducted with human participants is required to take out a public liability insurance policy. This obligation derives from Article 25(1) of the Act on the Professions of Physician and Dentist. The policy should cover all sites participating in the trial and must be in place before the first participant is enrolled.
Insurance does not exclude criminal liability — this must be clearly understood. It protects against financial claims by participants or their legal successors, but not against the consequences of conducting an experiment without the required Bioethics Committee approval or without properly informing participants.
The Bioethics Committee — when and how
The application to the Bioethics Committee is submitted by the Principal Investigator. The documentation must include at a minimum: the full trial protocol, template informed consent forms and participant information sheets, the CVs of the Principal Investigator and local investigators, the sponsor's details, and confirmation of insurance cover.
The waiting time for a resolution depends on the committee, but at least eight to twelve weeks from submission of complete documentation should be anticipated. The Committee may request supplementary information, which extends the procedure. No activities involving participants may take place before the favourable resolution has been delivered to the sponsor and the site.
Protocol amendments introduced after the opinion has been obtained require a fresh application for amendment — the Committee must approve every material modification. A change of site, the addition of a new trial arm, a change of Principal Investigator or an expansion of the inclusion criteria are typical events that trigger this obligation.
Timeline and budget — a realistic view
From the moment the protocol is commissioned to the first participant being enrolled typically takes between four and eight months. The main cost items are: protocol and documentation development, remuneration of the Principal Investigator and coordinator, site costs for clinical procedures and participant visits, laboratory costs, insurance, legal and regulatory services, and the Bioethics Committee review fee.
Underestimating any of these items at the planning stage is the most common cause of problems during implementation. Particularly frequently overlooked are the costs of laboratory tests at screening and during visits, documentation archiving fees, and the management of adverse events requiring reporting.
Summary
A well-conducted clinical trial of a food supplement is an investment that defends the product against challenge for years to come and opens the door to evidence-based communication. A poorly conducted one — without a proper legal basis, without a Bioethics Committee opinion, without duly obtained participant consent — is not only a legal risk for the sponsor, but above all a violation of the rights of those taking part in the experiment.
The key questions to ask before launching a project are: does the trial objective risk classifying the product as a medicinal product? Is the protocol consistent with the food supplement status of the product? Who will be the Principal Investigator and do they hold the necessary qualifications? What is the contract structure and who is responsible for each obligation? Does the budget account for all realistic costs?
It is worth knowing the answer to each of these questions before submitting the application to the Bioethics Committee.